Two-Dose Methotrexate for Ectopic Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194272
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 9, 2011
Bill and Melinda Gates Foundation
Information provided by:
University of Pennsylvania

Brief Summary:
This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.

Condition or disease Intervention/treatment Phase
Ectopic Pregnancy Drug: Methotrexate Phase 3

Detailed Description:
The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-Dose Methotrexate for Ectopic Pregnancy
Study Start Date : March 2001
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Methotrexate
    Two dose methotrexate
    Other Names:
    • Rheumatrex Dose Pack
    • Trexall

Primary Outcome Measures :
  1. Prevalence of side effects [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ]

Secondary Outcome Measures :
  1. Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of ectopic pregnancy via

    • D&E without products of conception identified on frozen pathology or
    • VABRA without products of conception identified with pathologic evaluation or
    • Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole
  • the subject is hemodynamically stable without signs of hemoperitoneum
  • laparoscopy has not been performed
  • the subject is able to return for frequent follow-up care
  • normal renal and liver function have been documented within 2 days
  • normal white blood count and platelet count have been documented as per laboratory standard
  • normal chest x-ray was obtained if the subject has a history of pulmonary disease
  • no history of allergy or sensitivity to methotrexate or any component of its formulation

Exclusion Criteria:

  • breastfeeding
  • laboratory evidence of immunodeficiency
  • alcoholism or chronic liver disease
  • the concomitant use of non-steroidal anti-inflammatory drugs
  • blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
  • active pulmonary disease
  • hepatic, renal, or hematological dysfunction
  • adnexal mass > or = 3.5 cm
  • presence of fetal cardiac motion
  • active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
  • subjects unable or unwilling to comply with study procedures or illiterate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194272

United States, California
University of Southern California Women's and Children's Hospital
Los Angeles, California, United States, 90033
United States, Florida
University of Miami
Miami, Florida, United States, 33101
United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Bill and Melinda Gates Foundation
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania

Responsible Party: Kurt T Barnhart, MD, MSCE, University of Pennsylvania Identifier: NCT00194272     History of Changes
Other Study ID Numbers: 701460
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by University of Pennsylvania:
Ectopic pregnancy

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors